BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 4488322 · Received February 5, 2015

    Report

    Report Number
    3005099803-2015-00258
    Event Type
    Malfunction
    Date Received
    February 5, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 19, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED ISSUE OF BANDS FAILED TO DEPLOY. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SOME RESIDUE INDICATING USE/HANDLING. THE EXTENSION TUBE WAS WITHOUT ISSUE. THE SUTURE WAS INTACT AND ATTACHED TO THE TRIP WIRE LOOP. SIX LIGATION BANDS WERE PRESENT ON THE LIGATOR HEAD AND WERE MOVED OUT OF POSITION. ONE LIGATION BAND HAD BEEN DEPLOYED AND WAS NOT RETURNED. THE LIGATOR HEAD TEETH WAS BADLY DAMAGED. THE TRIP WIRE WAS NOT SECURED IN THE HANDLE ASSEMBLY SLOT AND THE PROXIMAL LOOP WAS RETRACTED INTO THE HANDLE ASSEMBLY. THE HANDLE ASSEMBLY SLOT AND TRIP WIRE DID NOT PRESENT EVIDENCE THAT THE TRIP WIRE HAD BEEN SECURED DURING USE. A FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED BY TURNING THE HANDLE KNOB AT 180º AND AN AUDIBLE CLICK WAS HEARD, NO ISSUE WAS NOTED. BASED ON THE CONDITION OF THE RETURNED DEVICE, IT DOES NOT APPEAR THAT THE TRIP WIRE WAS CINCHED IN THE HANDLE SLOT DURING USE AS INSTRUCTED IN THE DFU. THIS IMPACTED THE DEPLOYMENT ACTIVITY OF THE BANDS. THEREFORE THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS USER ERROR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN TURNED THE HANDLE IN ATTEMPT TO RELEASE THE BANDS; HOWEVER, THE LIGATION BANDS FAILED TO DEPLOY. THE PROCEDURE WAS NOT COMPLETED DUE TO LACK OF AVAILABILITY OF ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN TURNED THE HANDLE IN ATTEMPT TO RELEASE THE BANDS; HOWEVER, THE LIGATION BANDS FAILED TO DEPLOY. THE PROCEDURE WAS NOT COMPLETED DUE TO LACK OF AVAILABILITY OF ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84279 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542251 16719215

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR